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The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain

CompletedNot applicableNCT04081532
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Endometriosis is a chronic, incurable condition that affects about 10% of women of reproductive age. It is defined as a growth of cells similar to the womb lining outside of the womb in the pelvis, and is associated with chronic pelvic pain, excessive period pain, pain with sexual intercourse and difficulties in getting pregnant. If the disease is found only on the lining of the pelvis it is known as "superficial peritoneal" and is usually treated during a laparoscopic surgery by cutting out (excision) or burning off (ablation). However, many women do not find improvement in their symptoms after the surgery and can have complications from the procedure. The aim of this study is to determine if removal of the superficial peritoneal endometriosis improves pain symptoms and quality of life, which method of removal (excision or ablation) is more effective or if surgical removal is of no benefit to the patients and can potentially cause harm. The investigators plan to recruit up to 90 women from four NHS hospitals in Scotland over a period of 12 months. Women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy will be approached. Patients will be asked to read an information sheet about the trial. Women who consent to the trial will be randomised during the surgery, if superficial endometriosis is found, to either having the endometriosis removed or not. For this pilot, follow up will be at 3 and 6 months (and obtain permission to continue to follow them up at 12 and 24 months should time and finding permit). Patients who do not consent to take part in the trial will be asked if the investigators can collect data on their demographics and reasons on why they did not wish to take part.

Study details

Official title
The Effectiveness of Laparoscopic Treatment of Isolated Superficial Peritoneal Endometriosis for Managing Chronic Pelvic Pain in Women: a Randomised Controlled Feasibility Trial
Interventions
  • Procedure: surgical removal of superficial peritoneal endometriosis
Sponsor
University of Edinburgh
Collaborators
NHS Grampian; University of Nottingham
Start date
2019-09-30
Primary completion
2021-04-01
Sex
Female
Age range
from 18 Years to 55 Years
Results posted
No results posted in this snapshot
Countries
United Kingdom
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Undergoing laparoscopy for the investigation of chronic pelvic pain * In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically) * Able to give informed consent Exclusion Criteria: * Previous surgical diagnosis of endometriosis * Pregnant or are actively trying for pregnancy within the next six months * Deep endometriosis or ovarian endometrioma on imaging or at laparoscopy * Peritoneal 'pockets' only noted at laparoscopy

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04081532